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NCT00317720 · ClinicalTrials.gov registry record · Phase 1
Trastuzumab and RAD001 in Patients With Human Epidermal Growth Receptor 2 (HER-2) Overexpressing Breast Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00317720: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00317720 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00317720, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
Primary Objectives: 1. To identify the optimal dose and pharmacokinetics of RAD001 in combination with trastuzumab in a Phase I trial 2. To determine the efficacy of RAD001 plus trastuzumab in HER-2-overexpressing patients with resistance to trastuzumab-based therapy for metastatic breast cancer in a Phase II trial. 1. Trastuzumab resistance will be defined as the development of progressive disease after trastuzumab-based therapy for metastatic breast cancer. Patients who develop metastases while receiving adjuvant or neoadjuvant trastuzumab will be eligible. 2. Efficacy would be measured by the rate of objective response plus stable disease lasting 6 months (complete response (CR) + partial response (PR) + stable disease SD). Secondary objectives: 1. To determine the pharmacokinetics of RAD001 in combination with trastuzumab. In the phase II portion of the study, pharmacokinetic studies will be optional. 2. To determine the nature and degree of toxicity of RAD001 in combination with trastuzumab in this cohort of patients 3. To determine expression levels of total and phosphorylated mTOR and p70S6K-T389-P as well as relevant downstream signaling components (e.g., S6, 4E-BP1) in pre- and post- treatment tumor samples. 4. To correlate biomarker expression with response to therapy.
Primary Outcome
In Phase I, two dose levels of RAD001 were studied: 10 mg (dose level 1) and 5 mg (dose level -1) where each dose was evaluated after cycle 1. At MDACC, the Continual Reassessment Method (CRM) for determining Maximum Tolerated Dose (MTD) was applied to the two predefined RAD001 dose levels; and at DFCI/BIDMC, a 3 x 3 study design was utilized. Optimal dose defined as the dose most closely associated with a toxicity rate of 0.20, and toxicity defined as any grade 3 or 4 toxicity (based on Common
Interventions
- DRUG Trastuzumab
- DRUG RAD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2006-04 |
| Est. Completion | 2013-02 |
| Phase | Phase 1 |
What the finished NCT00317720 record still lists
NCT00317720 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Trastuzumab is the first listed.
NCT00317720 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00317720 about?
NCT00317720 is a clinical study titled "Trastuzumab and RAD001 in Patients With Human Epidermal Growth Receptor 2 (HER-2) Overexpressing Breast Cancer". Primary Objectives: 1. To identify the optimal dose and pharmacokinetics of RAD001 in combination with trastuzumab in a Phase I trial 2. To determine the efficacy of RAD001 plus trastuzumab in HER-2-overexpressing patients with resistance to trastuzumab-based therapy for metastatic breast cancer in...
What is the current status of trial NCT00317720?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2006-04. Estimated completion is 2013-02.
What interventions are being tested in trial NCT00317720?
The interventions under investigation include: Trastuzumab (DRUG), RAD001 (DRUG).
Who is sponsoring clinical trial NCT00317720?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00317720's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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